NCT07820527Not yet recruiting
TCD and ONSD for Early Risk Stratification of Traumatic Brain Injury
Combined Transcranial Doppler and Optic Nerve Sheath Diameter for Early Risk Stratification of Patients With Traumatic Brain Injury in the Emergency Department
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
This observational study aims to evaluate the combined use of transcranial Doppler (TCD) and optic nerve sheath diameter (ONSD) ultrasound for early risk stratification of adults with traumatic brain injury (TBI) presenting to the Emergency Department. The study will assess whether ONSD measurements and TCD-derived middle cerebral artery pulsatility index (MCA-PI), in addition to clinical and computed tomography findings, can help identify patients at increased risk of early neurological deterioration. Adult patients with acute TBI and a Glasgow Coma Scale (GCS) score of 13 or less will be enrolled. TCD and ONSD measurements will be performed at emergency department presentation, with repeat measurements at 24 hours when clinically feasible in patients who have not developed early neurological deterioration. The primary outcome is early neurological deterioration within 24 hours.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 31 Aug 2026
- Start date
- Oct 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Assiut University
- Diseases
- High blood pressure
- NCT number
- NCT07820527
What you commit to
- Study type: Observational
- Planned participants: 60
- From Oct 2026 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous decompressive craniectomy.
Other
- Immediate neurosurgical indication requiring urgent intervention.
- Immediate life-saving procedure or clinical instability preventing safe completion of the research ultrasound assessment.
- Significant orbital trauma or ocular pathology interfering with reliable optic nerve sheath diameter measurement.
- Inadequate temporal acoustic window preventing reliable middle cerebral artery transcranial Doppler assessment.
- Refusal to participate or withdrawal of consent.
Who the study is looking for
- Adults aged 18 years or older.
- Acute traumatic brain injury diagnosed clinically and/or radiologically.
- Initial Glasgow Coma Scale (GCS) score ≤13.
- Initial CT brain scan demonstrating a traumatic intracranial structural lesion.
- No indication for immediate neurosurgical intervention at initial assessment.
- Initially managed conservatively/non-operatively according to the treating team.
- Informed consent obtained from the patient or legally authorized representative.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assiut university Hospitals Coordinator of this site? Confirm its status | Asyut | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.